Reduced Radiation in Patients With Diffuse Large B-cell Lymphoma (DLBCL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01186978
First received: August 19, 2010
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

This study will evaluate whether a reduction in the radiation dose and field size will maintain a high rate of local control while minimizing the risk of acute and late toxicity.

Hypothesis- The radiation dose and treatment volume can be safely reduced from 30 Gy to 20 Gy while maintaining high rates of local control in patients who had a negative PET scan following rituximab-containing chemotherapy.


Condition Intervention
Diffuse Large B-cell Lymphoma
Radiation: Radiation Therapy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dose-Reduced Consolidation Radiation Therapy in Patients With Diffuse Large B-cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • To determine if high rates of local control can be maintained after a reduction in the RT dose and volume after 4 to 6 cycles of rituximab containing chemotherapy. [ Time Frame: 5 year ] [ Designated as safety issue: No ]
    This trial will accrue 62 patients over a time period of approximately 5-6 years. The primary objective is to determine whether the observed 5-year LC rate, estimated from the Kaplan-Meier curve of time-to-local failure, is as high as that observed in historical controls, i.e., 0.90.


Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 5 year ] [ Designated as safety issue: No ]
    Progression-free survival (PFS) will be defined as the time from on-study to disease progression or death due to any cause, whichever comes first.

  • Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Overall survival will be defined as the time from on-study to death due to any case.

  • To examine patterns of failure [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    To examine the patterns of failure, we will tabulate the various ways that patients failed up until the time of the analysis. For example, these ways will include local only, local + distant, and distant only.


Estimated Enrollment: 62
Study Start Date: October 2010
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single arm
This phase II study will evaluate whether a reduction in the RT dose, concomitant with a decrease in the RT field size, in patients that achieve CR and have a negative post-chemotherapy PET scan following 4 to 6 cycles of rituximab containing chemotherapy, will be associated with a low risk of in-field failure. The goal of this approach is to maintain excellent control rates while minimizing the risk of acute and late toxicity.
Radiation: Radiation Therapy
1.5-2 Gy per fraction to a total dose of 19.8-20 Gy with radiation given 5 days/week

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic documentation of diffuse large B-cell lymphoma, or any of its variants as defined in the WHO classification
  • Completion of at least 4 cycles of a rituximab-containing, anthracycline-based combination chemotherapy
  • Negative post-chemotherapy (or interim) PET scan
  • Absolute neutrophil count greater than 1500 and platelet count greater than 40,000
  • Negative pregnancy test in women of child-bearing potential

For patients with HIV/AIDS, the following must be true:

  • The patient is compliant on combination anti-retroviral therapy (CART)
  • The patient has CD4 count ≥ 200 at time of diagnosis

Exclusion Criteria:

  • Any contraindications to irradiation
  • Primary CNS lymphoma
  • HIV/AIDS
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01186978

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Christopher Kelsey, MD    919-668-5213    christopher.kelsey@duke.edu   
Principal Investigator: Christopher Kelsey, MD         
Durham Regional Hospital Recruiting
Durham, North Carolina, United States, 27704
Contact: Bridget Koontz, MD    919-470-8600      
Principal Investigator: Bridget Koontz, MD         
Duke Raleigh Hospital Enrolling by invitation
Raleigh, North Carolina, United States, 27609
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Christopher Kelsey, MD Duke University Medical Center, Radiation Oncology
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01186978     History of Changes
Other Study ID Numbers: Pro00025164
Study First Received: August 19, 2010
Last Updated: August 6, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on August 20, 2014